The Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is ...
In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...
The Bermuda Health Council has paused further guidance on the price of pharmaceuticals in the wake of “rapid changes” in the ...
Novo Nordisk has been sent a warning letter from the FDA for a series of violations of postmarketing adverse drug experience (PADE) regulations, including failure to report side effects among patients ...
The FDA has faced an extraordinary convergence of political, scientific, legal, and operational pressures over the last year.
PDA Publishes Revised Technical Report No. 56: A Clear, Phase Appropriate Roadmap for GMP Compliant Development of Biological Drug Substances Technical Report No. 56 (Revised 2026) outlines a ...
Under guidance released Monday, the FDA said it may consider approving vape flavors such as mint, coffee, tea and spices like clove or cinnamon. But it will continue rejecting sweet or fruit-flavored ...
Interim results from RAINIER reveal that an 80 mg dose of povetacicept every four weeks delivered a 52% reduction in protein ...
The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay Prasad will help clear the path.
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Biote projects 2026 revenue above $190M as company expands sales force and invests in tech platform
Guidance shifted from reiterating 2025 revenues above $190 million and adjusted EBITDA above $50 million to projecting 2026 revenues above $190 million and adjusted EBITDA greater than $38 million, ...
ARLINGTON, MA - March 11, 2026 - PRESSADVANTAGE - The importance of drug testing in the community is a subject that ...
The drug leucovorin was touted by the Trump administration in September as a potential treatment for thousands of children with autism. Now, some parents and guardians of children with autism say they ...
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